Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

Price Vision Group

Status and phase: Completed; Phase 2

Conditions: Keratoconus; Post-Refractive Ectasia

Treatments: Drug: Riboflavin; Device: UVX light

Study type: Interventional

Funder types: Industry

Identifiers

NCT01143389

2010-0243

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.

Full description

The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.

Enrollment: 510 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 10 years of age or older

2. Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:

   1. An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
   2. An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
   3. A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
   4. Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.

3. Subjects with keratoconus diagnosis only:

   a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring

4. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:

   Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks

5. Signed written informed consent

Exclusion criteria

• 1. Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.

  2. Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:

  a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.

  5. A known sensitivity to treatment medications. 6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.

  6. Pregnancy (including plan to become pregnant) or lactation during the course of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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510 participants in 2 patient groups

Riboflavin 0.1% eyedrops every 5 minutes

Active Comparator group

Description:

The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).

Treatment:

Drug: Riboflavin

Device: UVX light

Riboflavin 0.1% eyedrops every 2 minutes

Active Comparator group

Description:

The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).

Treatment:

Drug: Riboflavin

Device: UVX light